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It’s a Matter of Consent: Considering a Patient’s Rights.

Author: Sara Patricia Chavarria



Time: 2 class periods
Preparation
Time:
Copy overhead 1 for display
Materials: Overhead sheets
Overhead 1

 


Abstract
In this explain lesson, students will use their biographical research results to evaluate how a patient’s rights charter might be created. They will create a patient’s list of medical rights and then compare their list to an informed consent primer prepared by the National Cancer Institute. Throughout the activity students are encouraged to raise questions about how to deal with an individual patient’s rights especially as this is a role they will find themselves in throughout their lifetimes.

Objectives
Students will be able to:
i. Create a Patient’s Rights Charter after discussions of past experiments with such rights charters using the biographical posters in order to stimulate discussions on current attempts to create a Patient’s Rights Charter.
ii. Critically review and rewrite the charter after comparing the class list to the informed consent notes published by the National Cancer Institute.

National Council for History in the Schools:
Historical Thinking Standards

  • Standard 5B: Marshal evidence of antecedent circumstances and contemporary factors contributing to problems and alternative courses of action.
  • Standard 5C: Identify relevant historical antecedent.
  • Standard 5D: Evaluate alternative courses of action.

World History Standards

  • Era 6, Standard 2: How European society experienced political, economic, and cultural transformations in an age of global intercommunication, 1450-1750.
    • Standard 2D: The student understands how the Scientific Revolution contributed to transformations in European society.
  • Era 6, Standard 6: Major global trends from 1450-1770
  • Era 8, Standard 3: The search for peace and security in the 1920s and 1930s.
    • Standard 3C: The student understands the interplay between scientific or technological innovations and new patterns of social and cultural life between 1900 and 1940.
  • Era 9, Standard2: The search for community, stability, and peace in an interdependent world.
    • Standard 2A: The student understands how population explosion and environmental change have altered conditions of life around the world.
    • Standard 2E: The student understands major worldwide scientific and technological trends of the second half of the 20th century.

Teacher Background

Related and Resource Websites
http://www.cancer.gov/clinicaltrials/conducting/informed-consent-guide
http://humansubjects.stanford.edu/medical/SUSampCons.html

 

 

Activity
Day 1
1. In the previous lesson it became apparent that in order for any innovative medical breakthroughs to occur, scientists and physicians needed to test their ideas on human subjects at some point. This raises ethical concerns on the issue of consent and human subjects.

2. Ask the following question: Would you have liked to be the person receiving the blood transfusion performed by James Blundell in 1929 knowing that the idea of blood types had not been discovered yet? What if you were really ill and desperately needed help?

3. This is a valid dilemma. Pose the following questions (write each question on different overheads and fill in with discussion content) and allow for discussion:

a. How do we convince people to be a part of experiments that might help but may also have some negative impact(s) or may not be helpful at all?
b. Should we tell patients that they are part of an experiment? Why or why not?
c. Do you think people would want to know that they are a part of an experiment?
d. Is ignorance bliss?
e. Can you trust your physician if he/she really wants the experiment to take place?

4. Using the previous research (posters), student groups will now identify problems with medical studies or experimentation procedures. They will discuss how to address those problems.

5. Place students in groups of 4-5 and have them write down ideas for how they would like to be treated if they were ill.

6. Take it a step further and write down ideas on how they would like to be treated if they were asked to participate in an experiment.

7. Take those ideas and start creating a Patient’s Rights Charter list (aim for a list of 5-10 rights per group).

8. When done, as a class, negotiate how best to create a Class Charter for Patient’s Rights (no limit on final number of rights). One student can write down the ideas on an overhead while the discussion and negotiations take place.

9. When all ideas are exhausted, create a poster of the charter and mount on the wall.

Day 2
10. Students will now compare their charter to the Informed Consent laws.

11. Define Informed Consent (Overhead page 1a) and explain that they are in place to protect participants of clinical trials (what we call modern medical experiments).

12. Define Clinical Trials (Overhead page 1a) – modern equivalent of medical experimentation using human subjects and animals as well. Rule of Thumb: Risks cannot outweigh the Benefits!!!

13. Show pages 1b and 1c of Overhead 1 and go over the additional materials that should be a part of an informed consent document.

14. Did the class charter cover the clinical trial participation rights addressed in pages 1b and 1c of Overhead 1?

a. How about the right to leave a study at any time?
b. How about the right to be continually informed and updated on the study results?
c. How about the formation of the some sort of review panel like the Institutional Review Boards (IRBs) to review proposals for medical clinical trials? (IRBs review proposals and represent various interest groups such as medical personnel, investors, patients, citizens, etc.)

Closure
The class may want to come up with a new Class Patient’s Rights Charter incorporating what they have learned from the materials seen on Overhead 1.

Homework

Embedded Assessment
The ability to draw upon and analyze historical practices and experiences to form the basis of potential present day solid medical experimentation practices can be assessed in the student-developed patients’ rights charter


PULSE is a project of the Community Outreach and Education Program of the Southwest Environmental Health Sciences Center and is funded by:


an
NIH/NCRR award #16260-01A1
The Community Outreach and Education Program is part of the Southwest Environmental Health Sciences Center: an NIEHS Award

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Supported by NIEHS grant # ES06694


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Last update: November 10, 2009
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